Biosafety is used to describe efforts to reduce and eliminate the potential risks resulting from biotechnology and its products. It has similarly been defined as “the avoidance of risk to human health and safety, and to the conservation of the environment, as a result of the use for research and commerce of infectious or genetically modified organisms” (Zaid, 2001). Relevant scientific disciplines that underpin biosafety studies include molecular biology, plant breeding, genetics, plant pathology, agronomy, weed science, entomology and ecology, among others. Therefore a large amount of scientific knowledge and data has a direct impact on biosafety, and it can be a difficult process to collate this information in a credible way in order to create a balanced view.

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One of the major problems within the scientific debate on GMOs relates to informational limitations. Most of the available scientific information regarding GMOs is held by corporate organisations and research institutions whose motives are sometimes questioned, as they are viewed as having a strong financial interest in ensuring that GMOs are perceived as positive contributions to human well-being. On the other hand, some of the most well publicised opposition to GMOs has sometimes taken the form of high profile press announcements that do not stand up under scrutiny. It seems apparent that, whilst the basic underlying science remains in dispute, there is a continuing need for impartial organisations to play a role in compiling, coordinating, and making available unbiased and reliable information on biosafety from different countries. Such widespread dissemination of scientific information underpins all of ICGEB’s biosafety undertakings.

ICGEB Biosafety Unit

Padriciano, 99

34012 Trieste, Italy

Tel.: +39-040-3757320

Fax: +39-040-226555

Email: biosafe@icgeb.org

Heightened global environmental awareness and concern over accelerating ecological degradation during the latter quarter of the 20th Century resulted in a desire by the international community to push the protection of the environment higher up the political agenda. These efforts came to fruition in 1992 when the Convention on Biological Diversity (CBD) came into force. Its objectives include “the conservation of biological diversity, the sustainable use of its components and the fair and equitable sharing of the benefits arising out of the utilisation of genetic resources”. During the elaboration of the Convention, negotiators recognised that biotechnology could contribute to achieving these objectives, if developed and used with adequate safety measures for both the environment and human health. Accordingly, procedures were developed to address the safe transfer, handling and use of any LMO (“living modified organism”; used interchangeable with “genetically modified organism” [GMO] in these webpages) resulting from biotechnology that may have an adverse effect on the conservation and sustainable use of biological diversity (Article 19.3, CBD). These procedures formed the Cartagena Protocol on Biosafety, which came into force in 2003 and has 138 signatory countries to date (January 2007). Parties lacking a cohesive biosafety policy undertook, or are currently undertaking, a number of initiatives to put a national framework in place in order to comply with the CPB. This has resulted in a great demand for biosafety-related information, training programmes, and capacity-building projects.

This period of heightened political activity in environmental protection has coincided with a concomitant rise in genetically modified (GM) crop cultivation. Since 1996, the global area of GM crops under cultivation has grown at more than 10 % per annum. The estimated total global cultivated area of approved GM crops in 2005 was 90 million hectares, (222 million acres). Further, more than one-third (38 %) of the 2005 total, equivalent to 33.9 million hectares, was grown in developing countries (James, 2005). Among the top 10 GM crop-growing countries by area, the USA, Argentina, Canada, Uruguay, and Australia are currently not parties to the CPB. At the same time, many developing countries that have ratified the CPB are still in the process of elaborating a regulatory framework governing the import or cultivation of GM crops. This has led to the current situation where different strategies and standards have been adopted at the national level, caused by the different infrastructures available in developed and developing countries, and has resulted in much confusion and difficulty in harmonising environment and trade agreements and regulations.

Based upon ICGEB’s long-standing activities in biosafety, we have identified the main issues derived from the deliberate introduction of GM crops (and their derived products) into the environment or onto the market of concern today. These have been classified as:

Risks for animal and human health:
toxicity & food/feed quality/safety; allergies; pathogen drug resistance (antibiotic resistance), impact of selectable marker

Risks for the environment:
persistency of gene or transgene (volunteers, increased fitness of GM crop, invasiveness) or of transgene products (accumulative effects); susceptibility of non-target organisms; change in use of chemicals in agriculture; unpredictable gene expression or transgene instability (gene silencing); environmentally-induced (abiotic) changes in transgene expression; ecological fitness; changes to biodiversity (interference of tri-trophic interactions); impact on soil fertility/soil degradation of organic material

Horizontal gene transfer:
genetic pollution through pollen or seed dispersal & horizontal gene transfer (transgene or promoter dispersion); transfer of foreign gene to micro-organisms (DNA uptake) or generation of new live viruses by recombination (transcapsidation, complementation, etc.)

Risks for agriculture:
resistance/tolerance of target organisms; weeds or superweeds; alteration of nutritional value (attractiveness of the organism to pests); change in cost of agriculture; pest/weed management; unpredictable variation in active product availability; loss of familiarity/changes in agricultural practise

General concerns:
detection and analytical methods; ethical issues (eg. labelling); substantial equivalence; risk assessment/ risk management; general biosafety; public attitudes, perception; legislation (incl. liability & redress); monitoring; socio-economics (eg. situation of poor farmers in developing countries); IPR (Intellectual Property Rights); GM traceability / commodity segregation

Scientific publications regarding these topics can be found via our Biosafety Bibliographic Database